Pharming announces restructuring plan
LEIDEN, THE NETHERLANDS -- (Marketwire) -- 08/02/12 -- Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced a strategic restructuring plan of its Dutch operations designed to accelerate the Company's path to sustainability and future profitability. The proposed plan, which necessitates a request for "collective redundancies", was filed with the Dutch authorities (UWV Werkbedrijf, in accordance with the "Wet Melding Collectief Ontslag"). The process entails a formal procedure, required when there is a need for downsizing of an organisation by 20 staff or more. The plan continues the restructuring initiated in June by the closure and subsequent sale of Pharming's US facility
Post the completion of this restructuring, the organisation will have maintained full capabilities to execute technology transfers of platform technology and product processes as well as retaining all product development associated know-how. Furthermore, Pharming will continue to participate in existing collaborative product development and to pursue potential partnerships in the future.
The Company will thus maintain sufficient personnel to achieve these strategic objectives by aligning the staffing resources and potential partnering requirements of the organisation with its strategic needs post the anticipated finish of Study 1310 (our US pivotal trial) and submission of the Ruconest BLA to the FDA .
As a result of the restructuring, the Company aims to reduce costs by approximately EUR 3.5-5 million annually over the coming 12-18 months. The timing of the plan will be influenced by external (e.g. authorities and business development activities) and internal influences (operational deliverables).
Pharming's Works Council has yet to advise on the restructuring plan, according to the Works Councils Act art 25. Following the decision of the authorities and the advice of the Works Council, the plan will be implemented.
"This restructuring will allow Pharming to implement the next steps in its business strategy: transitioning from a mainly internal research driven model to a market driven, externally focused, collaborative research and development model", said Sijmen de Vries, CEO. "It is clear that Pharming must adopt a leaner, more cash efficient business model if it is to survive in the longer term and we firmly believe that these actions will help to re-position Pharming to create value for our stakeholders."
RUCONEST® Phase III Study
Pharming is conducting a Phase III clinical study with RUCONEST® under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). RUCONEST is being evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-controlled Phase III study at a dosage strength of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. Santarus has licensed certain exclusive rights from Pharming to commercialize RUCONEST in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study. The study is expected to be completed by the end of the third quarter of 2012.
About RUCONEST® and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RUCONEST is produced through Pharming's proprietary technology in milk of transgenic rabbits and is approved in Europe for treatment of acute angioedema attacks in patients with HAE. RUCONEST® is an investigational drug in the U.S. and has been granted orphan drug designation for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum (OMX: SOBI). RUCONEST® is partnered with Santarus, Inc (NASDAQ: SNTS) in North America where the drug is undergoing Phase III clinical development. The product is also being evaluated for follow-on indications in the areas of transplantation and reperfusion injury. The advanced technologies of the Company include innovative and validated platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. A feasibility study, using the validated transgenic rabbit platform, aimed at the development of recombinant Factor VIII for the treatment of Haemophilia A is underway with partner, Renova Life, Inc. Additional information is available on the Pharming website, www.pharming.com. To download the Pharming Group Investor Relations App, click here.
This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.
# # #
Press release (PDF): http://hugin.info/132866/R/1631393/523012.pdf
This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1631393]Contact Sijmen de Vries CEO: T: +31 (0)71 524 7400 Karl Keegan CFO: T: +31 (0)71 524 7400 FTI Consulting Julia Phillips John Dineen T: +44 (0)207 269 7193 NEXT ARTICLE